Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000215527
Ethics application status
Approved
Date submitted
9/01/2024
Date registered
5/03/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
5/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing complication rates of magnetic ureteric stent and stent on extraction strings for kidney stones
Scientific title
Evaluation of complication rates with magnetic stents compared to stent on extraction string in patients after uncomplicated ureteroscopy – randomised controlled trial
Secondary ID [1] 311286 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney stones 332523 0
Condition category
Condition code
Surgery 329210 329210 0 0
Surgical techniques
Renal and Urogenital 329211 329211 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the operating room, ureteroscopy is performed for treatment of kidney stone disease., the average time is ~60 minutes. After ureteroscopy a magnetic ureteric stent will be inserted by the operating surgeon which takes ~ 2 minutes before the procedure is completed.
This magnetic stent will then be removed by Urology Nurse routinely at day 7 after the ureteroscopy. This is performed in the outpatient department by inserting a magnetic catheter. This procedure takes < 5 minutes.
Electronic medical records will be used to monitor adherence.
Intervention code [1] 327733 0
Treatment: Surgery
Intervention code [2] 327734 0
Treatment: Devices
Comparator / control treatment
In the operating room, ureteroscopy is performed for treatment of kidney stone disease. After ureteroscopy a ureteric stent on extraction strings will be inserted by the operating surgeon.
This stent on extraction strings will then be removed by Urology Nurse in the outpatient department by pulling on the strings.
Control group
Active

Outcomes
Primary outcome [1] 337050 0
Complication rate of stent removal
Timepoint [1] 337050 0
Primary stent removal will occur at 7 days post procedure
Secondary outcome [1] 430477 0
Pain during stent removal
Timepoint [1] 430477 0
At stent removal 1 week post procedure
Secondary outcome [2] 430478 0
Ureteric stent irritation
Timepoint [2] 430478 0
1 week post procedure (prior to stent removal)
Secondary outcome [3] 430479 0
Stent irritation
Timepoint [3] 430479 0
1 week post procedure (prior to stent removal)
Secondary outcome [4] 430480 0
Complication rate - urinary tract infection
Timepoint [4] 430480 0
30 days post-procedure
Secondary outcome [5] 431904 0
Stent irritation
Timepoint [5] 431904 0
1 week post procedure (prior to stent removal)
Secondary outcome [6] 431905 0
Stent irritation
Timepoint [6] 431905 0
1 week post procedure (prior to stent removal)

Eligibility
Key inclusion criteria
• Sex: Male and female
• Age: 18 years and above
• Planned definitive ureteroscopy for urolithiasis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Expected to require MRI investigations within the next week.
• Patients that are pregnant
• Intra-operative finding or complication that would change usual post-operative plan or follow up
• Patients with untreated pre-operative urinary tract infection prior to procedure
• Urothelial malignancy impacting ureteric stent choice
• Patients with significant medical conditions that contra-indicate stent insertion will not be included in the study such as outlet obstruction and bladder fistula
• Unable to provide informed consent or meet study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The main objective of this study is to compare the complication rates of stent removal between magnetic stents and stents on extraction string. The difference in complication rates will be tested using a Chi-square test or Fisher’s exact test if the data is sparse. A binary logistic regression will be used to calculate the odds ratio and 95% confidence intervals to quantify the difference in likelihood of complication rate between the two types of stents.

The analysis will be conducted based on the intention-to-treat principle, and missing data will be handled using multiple imputation analysis using Monte-Carlo Markov-Chain (MCMC) method.

To compare the USSQ scale score for each domain, independent samples t-test or Wilcoxon’s ranks-sum test will be used depending on whether the scores are normally distributed or not. Patient-reported outcome measures will be compared using independent samples t-test for continuous outcomes and Chi-square or Fisher’s exact test for categorical outcomes. The VAS at stent removal will be compared using Wilcoxon’s rank-sum test. The 30-day complication rate will be compared using Chi-square or Fisher’s exact test if the data is sparse. The odds ratio estimate based on logistic regression will be used to compare the likelihood of repeating the procedure again and recommending it to a friend. Descriptive statistical measures will be used for cost analysis.

All statistical tests will be performed at an overall significance level of .05. The statistical analysis will be performed in SPSS, version 27.0 or STATA, version 17.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25980 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 25981 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 41831 0
2148 - Blacktown
Recruitment postcode(s) [2] 41832 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 315749 0
Hospital
Name [1] 315749 0
Royal North Shore Hospital, Reserve Road, St Leonards, New South Wales, 2056
Country [1] 315749 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital, Reserve Road, St Leonards, New South Wales, 2056
Address
Reserve Road, St Leonards, New South Wales
Country
Australia
Secondary sponsor category [1] 317863 0
Hospital
Name [1] 317863 0
Blacktown Hospital, Blacktown Road, Blacktown New South Wales 2148
Address [1] 317863 0
Country [1] 317863 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314439 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 314439 0
Ethics committee country [1] 314439 0
Australia
Date submitted for ethics approval [1] 314439 0
24/10/2023
Approval date [1] 314439 0
08/01/2024
Ethics approval number [1] 314439 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131586 0
Dr Ankur Dhar
Address 131586 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2056
Country 131586 0
Australia
Phone 131586 0
+61 2 8890 6693
Fax 131586 0
Email 131586 0
[email protected]
Contact person for public queries
Name 131587 0
Paul Kim
Address 131587 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2056
Country 131587 0
Australia
Phone 131587 0
+61 299267111
Fax 131587 0
Email 131587 0
[email protected]
Contact person for scientific queries
Name 131588 0
Ankur Dhar
Address 131588 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2056
Country 131588 0
Australia
Phone 131588 0
+61 299267111
Fax 131588 0
Email 131588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data regarding indications, complications (including patient scores) can be shared
When will data be available (start and end dates)?
Data available for 5 years after publication of study
Available to whom?
De-identified dataset may be shared will relevant researchers after their request has been reviewed by study group.
Available for what types of analyses?
De-identified data can be provided for use in systematic reviews
How or where can data be obtained?
Data requests from relevant researchers can be sent to the principal investigator (Ankur Dhar - [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.